Remote Oncology Biostatistics Manager

Sumitomo Pharma; Pierre (SD); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to lead statistical activities across oncology clinical programs. You will collaborate with cross-functional teams to ensure rigorous study design, analysis, and regulatory documentation.

This role emphasizes statistical leadership, regulatory knowledge, and mentorship on high-stakes trials. The position requires advanced degree in statistics with substantial experience in clinical development, strong SAS programming

Qualifications

• MS with 4+ years in Statistics/Biostatistics or a PhD in Statistics/Biostatistics.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH and other regulatory guidelines.
• Familiarity with CDISC standards (SDTM/ADaM).
• Experience designing, analyzing and reporting clinical trials.
• Proficiency in SAS; R desirable.

Responsibilities

• Serve as lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoints, sample size, randomization and analysis strategy.
• Contribute to development/review of clinical study protocols.
• Author/review SAPs (Statistical Analysis Plans).
• Collaborate on development/review of analysis datasets, tables, listings, and figures (TLFs).
• Review statistical outputs for quality and consistency of deliverables.
• Interpret study results and communicate findings to cross-functional teams.
• Contribute to preparation of CSRs, abstracts, publications, and regulatory documents.
• Support regulatory submissions and responses to health authorities.
• Collaborate with CRO statisticians and programming teams to ensure timely, high-quality deliverables.
• Ensure compliance with regulatory requirements and SOPs; participate in process improvements.
• Provide technical guidance and mentoring to junior statisticians.

Skills

Analytical skills

Communication skills

Cross-functional collaboration

Problem-solving

Attention to detail

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to lead statistical activities across oncology clinical programs. You will collaborate with cross-functional teams to ensure rigorous study design, analysis, and regulatory documentation.

This role emphasizes statistical leadership, regulatory knowledge, and mentorship on high-stakes trials. The position requires advanced degree in statistics with substantial experience in clinical development, strong SAS programming